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Improving New Learning and Memory in School Aged Children

Improving New Learning and Memory in School Aged Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04741360
Enrollment
9
Registered
2021-02-05
Start date
2017-10-25
Completion date
2021-11-15
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Pediatrics

Brief summary

The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.

Detailed description

The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.

Interventions

OTHERModified Story Memory Technique

10-session computerized program to improve new learning and memory

Sponsors

New Jersey Commission on Brain Injury Research
CollaboratorOTHER
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Be between the ages of 9 and 17. * Have sustained a TBI at least 1 year ago, that has affected his or her memory. * Be able to speak and read English fluently.

Exclusion criteria

* Diagnosis of MS, or neurological injury or disease in the past (like brain tumor or epilepsy). * History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis). * Uncontrolled seizures or other unstable medical complications.

Design outcomes

Primary

MeasureTime frameDescription
CVLT-C Learning Slope6 monthsMemory

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026